Interaction Between Fluvoxamine and Sildenafil
This study has been completed.
Sponsor:
University of Heidelberg
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00175981
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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Purpose
Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: sildenafil, fluvoxamine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males |
Resource links provided by NLM:
Further study details as provided by University of Heidelberg:
Primary Outcome Measures:
- Drug-induced changes of hand vein compliance
- Drug-induced changes of pharmacokinetic parameters
| Estimated Enrollment: | 12 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | November 2004 |
In a randomised, double-blind, placebo-controlled, cross-over study in healthy men we will assess the effect of oral fluvoxamine (50mg qd on day 1-3; 100mg qd on day 4-10) on sildenafil kinetics (single oral 50mg dose on day 11). Sildenafil plasma concentrations will be determined by LC/MS. We will also assess the effect of sildenafil on venodilation induced by a constant dose-rate of the NO-donor sodium nitroprusside (SNP) during preconstriction with phenylephrine (dorsal hand vein compliance technique).
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy, male individuals, age: 18-45.
- Able and willing to give written informed consent
Exclusion Criteria:
- Hypotension ( 65 mmHg diastolic and 100 mmHg systolic blood pressure)
- Bleeding disorders in medical history
- Intake of medication impairing platelet function or influencing coagulation (for example aspirin, NSAID and others) during the preceding 4 weeks
- Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, hyperhomocysteinaemia, smoking)
- Anatomic deformity of the penis like angulation, penile fibromatosis (peyronie’s disease) or diseases favouring priapism (e.g. leukaemia, plasmocytoma, sickle-cell anaemia)
- Regular medication and/or treatment with drugs within the preceding 4-6 weeks (exclusion has to be decided in each case)
- alcohol (>30 g/d) or drug abuse
- Acute or chronic illness
- Blood donation within the preceding 2 months
- Participation in clinical trial within 2 month before the study
- Drug and/or alcohol abuse.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175981
Locations
| Germany | |
| Dept. of Internal Medicine VI, University of Heidelberg | |
| Heidelberg, Baden-Württemberg, Germany, 69120 | |
Sponsors and Collaborators
University of Heidelberg
Investigators
| Principal Investigator: | Walter E Haefeli, MD | University of Heidelberg |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00175981 History of Changes |
| Other Study ID Numbers: | K058 |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 9, 2005 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Fluvoxamine Sildenafil Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Vasodilator Agents Cardiovascular Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 13, 2013